Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implants because the inner package labels display incorrect item, lot, and size information.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and packaging labeling issue where the correct information is available on the outer package, posing no direct physical hazard or risk of adverse health consequences.
Plain-English summary
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implant Systems due to labeling errors on the inner package. The inner package labels incorrectly list the item number, lot number, and size, while the outer package labels contain the correct information. The affected products are identified by outer package lot 63781164 and inner package lot 63773888.
The recalled implants were distributed nationwide in the United States and to several international countries, including Australia, Canada, and various European nations. The products are designed for use in the maxilla or mandible to replace missing teeth.
Healthcare providers and patients should verify the lot numbers on their inventory or installed devices against the recall notice. If the inner package labels match the incorrect details provided in the recall, the devices should be removed from use and returned to the manufacturer or an authorized representative.
The recalled product
- Product
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Outer Package Label: LOT: 63781164
- UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164
- Inner Package Label: LOT: 63773888
- UDI: (01) 00889024019508 (17) 220930 (10)63773888.
Distribution
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